Opioid Dependence
Conditions
Brief summary
This study will compare the effects of brief strengths-based case management (SBCM) to the effects of screening, assessment and referral alone (SAR) in opioid-dependent patients. Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per group) to receive 1) up to 6 sessions of SBCM; or 2) SAR. Follow-up assessments will be completed at 3 and 6 months, by staff who are blinded to treatment condition.
Detailed description
As addiction treatment becomes increasingly integrated into the medical care system, two models have rightly received a great deal of attention. The first is the use of Screening, Brief Intervention, and Referral to Treatment (SBIRT) models to identify cases, provide therapeutic contact, and refer the more severe cases to longer-term care. The second is the treatment of addictions using medical models of treatment, including those that can be implemented in primary care settings. Much less attention has been paid to optimizing strategies for bridging the gap between SBIRT and more intensive/longer-term treatment for those on the severe end of the spectrum. This factor is of critical importance for opioid dependent patients, whose needs are not met by brief interventions or brief treatment. Emergency room interventions for substance use disorders have been largely limited to brief interventions/SBIRT models, and these have focused primarily on alcohol. Although there is a substantial literature documenting the value of case management in linking drug users to treatment, this approach has not been applied to drug users in the emergency department (ED) setting. In a sample of opioid dependent patients seen in a medical ED who are not currently engaged in treatment, this study will compare the effects of brief strengths-based case management (SBCM) to the effects of screening, assessment and referral alone. Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per group) to receive 1) Screening, Assessment and Referral or 2) up to 6 sessions of SBCM based on the model previously implemented by Rapp and colleagues in prior studies. Staff who are blinded to treatment condition will complete follow-up assessments at 3 and 6 months. Aims of the study are to identify the main effects of SBCM on substance abuse treatment initiation and engagement, use of opioids and other drugs, and broader measures of health and life functioning; to examine the interactions between treatment assignment and selected participant attributes in predicting treatment initiation, engagement, and substance use outcomes; and to examine effects of treatment involvement on substance use outcomes in the two treatment groups. The proposed study will be the first trial using a case management approach to link drug dependent patients presenting in EDs to longer-term addiction treatment. It will be one of the first trials focusing specifically on opioid dependent patients in medical EDs. A further innovative feature is that the case management approach will emphasize linkage to pharmacotherapy, facilitating linkage to office-based buprenorphine, methadone, or naltrexone for patients who desire this treatment.
Interventions
BEHAVIORALStrengths-based Case Management (SBCM)
The six case management sessions for the proposed trial are based on those described in manuals developed by Dr. Rapp for two clinical trials, one supported by National Institute on Drug Abuse (NIDA) and another by the Centers for Disease Control (CDC). Each session is guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence in a specialty or primary care setting. Objectives from the earlier trials will be adapted to fit the specific context of this trial, linking with and staying in treatment following an emergency department visit. Initiation of the relationship between client and case manager begins immediately following random assignment and termination takes place when either (1) six sessions have occurred; (2) ninety days have elapsed; or (3) clients discontinue involvement.
BEHAVIORALScreening, Assessment, and Referral (SAR)
The research assistant will provide these participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet includes names, addresses, and phone numbers of local addiction treatment agencies. Because the emergency department does not currently screen or refer systematically, the SAR condition represents a level of care significantly higher than treatment as usual. Participants will also receive an informational pamphlet about drug use and its consequences, addiction, and treatment.
Sponsors
Wright State University
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Registration as patient in the ED during study screening hours; 2. Endorsement of three or more opioid dependence criteria on the DSM-IV checklist 3. Age 18 years or older; 4. Adequate English proficiency; 5. Ability to provide informed consent; 6. Self-report use of opioids in the last 30 days
Exclusion criteria
1. Inability to participate due to emergency treatment; 2. Significant impairment of cognition or judgment rendering the person incapable of informed consent. (e.g., traumatic brain injury, delirium, intoxication); 3. Status as a prisoner or in police custody at the time of treatment; 4. Current engagement in substance use disorder treatment; 5. Residence more than 50 miles from the location of follow-up visits; 6. Inability to provide sufficient contact information (must provide at least 2 reliable locators); 7. Unavailable for follow-up (e.g., planning to relocate within 6 months) 8. Prior participation in the current study. 9. Current participation in a research study related to substance use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of Treatment for Opioid Dependence | 3 months | Initiation is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D. |
| Engagement in Treatment for Opioid Dependence | 3 months | Using the same timeframe as initiation, engagement is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Outcome for Opioid Use | 3 months | Successful outcome will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed for opioid dependence, and 2) no more than two days of self-reported opioid use on the Form 90-D in the 4 weeks (30 days) prior to the 3-month evaluation. |
| Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire | 3 months | The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Raw domain score is the sum of respective item scores. All domain scores are reported between 4 and 20. |
| Initiation in Participants With Higher Levels of Environmental Instability at Baseline | 3 months | Initiation is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D. |
| Engagement in Participants With Higher Levels of Environmental Instability at Baseline | 3 months | Using the same timeframe as initiation, engagement is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Strengths-based Case Management (SBCM) Participants received up to six sessions of Strengths-based Case Management (SBCM) within 90 days of randomization. | 148 |
| Screening, Assessment and Referral (SAR) Participants received a detailed referral sheet, an informational pamphlet, and scripted feedback recommending they seek treatment. | 149 |
| Total | 297 |
Baseline characteristics
| Characteristic | Screening, Assessment and Referral (SAR) | Total | Strengths-based Case Management (SBCM) |
|---|---|---|---|
| Age, Continuous | 43.0 years STANDARD_DEVIATION 10.8 | 43.7 years STANDARD_DEVIATION 10.8 | 44.4 years STANDARD_DEVIATION 10.8 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian, Asian-American/Pacific Islander | 5 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 50 Participants | 97 Participants | 47 Participants |
| Race/Ethnicity, Customized Hispanic, Cuban | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic, Mexican | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic, New Mexican/Spanish-American | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic, Other Latin American | 9 Participants | 17 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic, Puerto Rican | 33 Participants | 76 Participants | 43 Participants |
| Race/Ethnicity, Customized Other ethnic group | 9 Participants | 18 Participants | 9 Participants |
| Race/Ethnicity, Customized White, not of Hispanic origin | 38 Participants | 74 Participants | 36 Participants |
| Sex: Female, Male Female | 23 Participants | 41 Participants | 18 Participants |
| Sex: Female, Male Male | 126 Participants | 256 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 150 | 1 / 150 |
| other Total, other adverse events | 3 / 150 | 2 / 150 |
| serious Total, serious adverse events | 17 / 150 | 8 / 150 |
Outcome results
Primary
Engagement in Treatment for Opioid Dependence
Using the same timeframe as initiation, engagement is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records.
Time frame: 3 months
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strengths-based Case Management (SBCM) | Engagement in Treatment for Opioid Dependence | 21.77 % days | Standard Deviation 35.07 |
| Screening, Assessment and Referral (SAR) | Engagement in Treatment for Opioid Dependence | 17.72 % days | Standard Deviation 30.99 |
p-value: 0.29ANOVA
Primary
Initiation of Treatment for Opioid Dependence
Initiation is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.
Time frame: 3 months
Population: Intention to treat
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Strengths-based Case Management (SBCM) | Initiation of Treatment for Opioid Dependence | Initiated | 85 Participants |
| Strengths-based Case Management (SBCM) | Initiation of Treatment for Opioid Dependence | Did Not Initiate | 63 Participants |
| Screening, Assessment and Referral (SAR) | Initiation of Treatment for Opioid Dependence | Initiated | 74 Participants |
| Screening, Assessment and Referral (SAR) | Initiation of Treatment for Opioid Dependence | Did Not Initiate | 75 Participants |
Secondary
Engagement in Participants With Higher Levels of Environmental Instability at Baseline
Using the same timeframe as initiation, engagement is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strengths-based Case Management (SBCM) | Engagement in Participants With Higher Levels of Environmental Instability at Baseline | 22.16 % days | Standard Error 5.21 |
| Screening, Assessment and Referral (SAR) | Engagement in Participants With Higher Levels of Environmental Instability at Baseline | 19.89 % days | Standard Error 4.76 |
p-value: 0.54ANOVA
Secondary
Initiation in Participants With Higher Levels of Environmental Instability at Baseline
Initiation is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.
Time frame: 3 months
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strengths-based Case Management (SBCM) | Initiation in Participants With Higher Levels of Environmental Instability at Baseline | 62.5 % of participants | Standard Error 7.8 |
| Screening, Assessment and Referral (SAR) | Initiation in Participants With Higher Levels of Environmental Instability at Baseline | 57.8 % of participants | Standard Error 7.2 |
p-value: 0.09ANOVA
Secondary
Number of Participants With Successful Outcome for Opioid Use
Successful outcome will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed for opioid dependence, and 2) no more than two days of self-reported opioid use on the Form 90-D in the 4 weeks (30 days) prior to the 3-month evaluation.
Time frame: 3 months
Population: Intention to treat
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Strengths-based Case Management (SBCM) | Number of Participants With Successful Outcome for Opioid Use | Successful outcome | 41 Participants |
| Strengths-based Case Management (SBCM) | Number of Participants With Successful Outcome for Opioid Use | No successful outcome | 107 Participants |
| Screening, Assessment and Referral (SAR) | Number of Participants With Successful Outcome for Opioid Use | Successful outcome | 28 Participants |
| Screening, Assessment and Referral (SAR) | Number of Participants With Successful Outcome for Opioid Use | No successful outcome | 121 Participants |
Secondary
Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Raw domain score is the sum of respective item scores. All domain scores are reported between 4 and 20.
Time frame: 3 months
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strengths-based Case Management (SBCM) | Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire | 11.23 units on a scale | Standard Deviation 4.61 |
| Screening, Assessment and Referral (SAR) | Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire | 11.22 units on a scale | Standard Deviation 4.45 |
p-value: 0.91ANOVA